Import of medicinal products for clinical studies in Norway
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General guideline regarding persission to import medicinal products for clinical studies in Norway. The guideline also covers the permission to export such products.
The approval to perform a clinical study does not include authorisation to manufacture and/or import medicinal products. Import in this sense includes bringing medicines from another EEA-country across the border to Norway. Import of medicinal products for clinical studies in Norway may only be performed by a company which has the necessary authorisation. It may be a wholesaler, a pharmacy or a manufacturer. See details in the table below. This is applicable for medicinal products for humans and animals.
Brief overview of types of companies having relevant authorisations
The table only gives a short overview. Please read the text below the table for further information.
|
Company type |
A. Products come the EU/EEA |
B. Products come from 'third contries', e.g. the United States, Switzerland. |
|
1. Wholesaler |
1A. Authorised wholesalers (with a permission issued by the Norwegian Medical Products Agency) may import medicinal products for clinical studies from authorised companies in the EU/EEA. |
1B. Import not permitted. This requires a manufacturing authorisation (issued by the Norwegian Medical Products Agency) for the import of medicinal products for clinical studies. |
|
2. Pharmacy |
2A. Norwegian pharmacies may import medicinal products for clinical studies from authorized companies, including manufacturers and wholesalers located in the EU/EEA area. |
2B. Import not permitted. This requires a manufacturing authorisation (issued by the Norwegian Medical Products Agency) for the import of medicinal products for clinical studies. |
|
3. Manufacturer |
3A. Manufacturing authorisation in the EU/EEA (including Norway) also give rights to perform wholesaler activities with medicinal products covered by the authorisation. This includes medicinal products for clinical studies, if the authorisation includes such medicinal products. Companies who have manufacturing authorisations issued by other Member States, must notify the Norwegian Medical Products Agency in advance if they intend to make use of the right to perform wholesaler activities in Norway. |
3B. Authorised manufacturers may import medicinal products for clinical trials from “third countries”, provided the authorisation includes such medications and import. This will be stated in the authorisation. |
Further information regarding the regulation and which companies having relevant authorisation
1. Wholesaler
Import permission depends on which country a medicinal product come from.
1A. The medicinal products come from the EU/EEA
Authorised wholesalers (with a permission issued by the Norwegian Medical Products Agency) may import medicinal products for clinical studies from authorised companies in the EU/EEA.
In order to confirm whether the company has a Wholesale Distribution Authoris
ation in Norway, check in the EudraGMDP database.
User manual for searching the database - wholesaler
Open the link above. Select WDA in the upper line. Under “Search”, select again WDA. For Country, select Norway. For Authorisation Holder, enter company name. The spelling must be precise, or enter known parts of the company name with *(asterisk) before and/or after (* indicates the parts that are not known). Then select “Search”. Select the appropriate authorisation number to open the relevant authorisation. Look for “Other products — Human investigational medicinal products” under section 3.4 for the Scope of authorisation.
Wholesalers who have authorisations from other EU/EEA-authorities (not from NoMA) may not perform wholesaler activities in Norway.
(WDA = Wholesale Distributor Authorisation)
1B. The medicinal products come from ‘third countries’, e.g. the United States, Switzerland
Not permitted. This requires a manufacturing authorisation (issued by the Norwegian Medical Products Agency) for the import of medicinal products for clinical studies.
2. Pharmacy
Import permission depends on which country a medicinal product come from.
2A. The medicinal products come from the EU/EEA
Norwegian pharmacies may import medicinal products for clinical studies from authorised companies, including manufacturers and wholesalers located in the EU/EEA area.
The sponsor should enter into a written agreement with the pharmacy concerning import of medicines for the clinical study, to make sure that the pharmacy is aware of their responsibilities as importer.
It is not permitted for Norwegian pharmacies to receive products from a pharmacy in another country, unless the Norwegian Medical Products Agency has issued a specific authorisation.
2B. Products come from 'third countries', e.g. the United States, Switzerland
Not permitted. This requires a manufacturing authorisation (issued by the Norwegian Medical Products Agency) for the import of medicinal products to clinical studies.
3. Manufacturer
3A. The medicinal products come from the EU/EEA
Companies holding a manufacturing authorization (MIA) for medicinal products for clinical studies (issued by the Norwegian Medical Products Agency) may import medicinal products provided their manufacturing license include importation of medicines for clinical studies(stated in MIA annex 2 part 2).
In order to confirm whether the company has a manufacturing authorisation in Norway, check EudraGMDP database.
Instructions for searches in the database
Open the link above. Select MIA in the upper line. Under “Search”, select again MIA. For Country, select Norway. For Authorisation Holder, enter company name. The spelling must be precise, or enter known parts of the company name followed by an (*). Then select “Search”. Select the appropriate authorisation number to open the relevant authorisation.
The text “Human investigational medicinal product” means that the authorisation includes medicinal products for clinical investigations.
Manufacturing authorisation in the EU/EEA (including Norway) also gives rights to perform wholesaler activities with medicinal products covered by the authorisation. This includes medicinal products for clinical studies, if the authorisation includes such medicinal products. Companies who have manufacturing authorisations issued by other Member States, must notify NoMA in advance if they intend to make use of the right to perform wholesaler activities in Norway.
EEA manufacturers wishing to distribute their own medicinal products for clinical studies in Norway, may notify NoMA by e-mail to post@dmp.no. Companies sending such a notification and who meet the criteria, will be included on a list which is published on the web site. The company may then import own produced products to Norway.
The notification shall contain the following information: The name and address of the holder of the manufacturing authorisation, address of the manufacturing site, including country and a copy of the relevant manufacturing license(s). It is should be stated that the notification concerns distribution of medication for clinical studies (any other medicinal products must be named).
Overview of EEA manufacturers who may distribute medicinal products for clinical studies in Norway. (Choose the link “Oversikt over EØS-tilvirkere med grossistvirksomhet i Norge”.)
3B. The medicinal products come from 'third countries', e.g. the United States, Switzerland
Import of medicinal products from outside the EEA territory, requires a manufacturing authorisation within the EU/EEA area, including an authorised qualified person who may release the medicinal product for clinical trials in all relevant countries in the EU/EEA.
Authorised manufacturers may import medicinal products for clinical trials from “third countries”, provided the authorisation includes such medications and import. This will be stated in the authorisation.
Use the same link as above to check whether the company has a manufacturing authorisation in Norway. Check that the authorisation includes investigational drugs.
Additional information
If the company (e.g. sponsor for the study) is not a Norwegian pharmacy or an approved wholesaler or manufacturer in Norway, and do not have a manufacturing authorisation as mentioned above, an agreement can be made with an approved wholesaler or a pharmacy willing to take responsibility for import and distribution of the medicinal products concerned.
It may be agreed that medicinal products for the clinical study are sent directly from abroad to the clinical trial site (e.g. a hospital department or a physician’s office), without physically being sent via a pharmacy or a wholesaler, but the pharmacy/wholesaler in Norway has to assume responsibility for all aspects related to the import (in accordance with the regulation relating to wholesaler activities, including good distribution practice (EU-GDP)). An approved manufacturer may also send medication for clinical studies directly from abroad to the clinical study site (hospital department or physician’s office).
It is not allowed to send medication for clinical studies from abroad to patients in Norway.
Pharmacies are not allowed to act as distributor and send medication for clinical studies to other pharmacies (they may only to act as importer). A pharmacy may prepare the medicinal products (e.g. by reconstitution etc) and send them directly to a hospital department or a physician’s office.
Companies in EU/EEA planning to import medicinal products to Norway must be identifiable with a Norwegian organization number in the Norwegian Business Registry (Brønnøysundregistrene) due to customs regulations. Norwegian organization numbers are obtained at the Central Coordinating Register for legal entities (CCR). Questions regarding customs regulations must be directed to Norwegian Customs.
For more information, see also Wholesaling in Norway based on a MIA or a WDA issued within the EU/EEA.
Fees
The Norwegian Medical Products Agency do not require fees for registrations, issuing authorisations or performimg inspections.
Export of medicinal products from clinical studies in Norway
An approval as wholesaler for medicinal products in EU/EEA also includes license to export medicinal products. (Norwegian wholesaler regulation § 1). Manufacturers of medicinal products may export the medications included in their MIA.
Wholesalers and manufacturers may export medicinal products remaining at the end of the clinical trial.
Other companies who may need export of remaining medication at the end the clinical study, have to send an application concering export to NoMA for each shipment. It is required to state which medicinal products, the amount to be sent, and who will be the recipient (name, address, contact person, etc). The application can be sent to post@dmp.no
The requirements are the same for export to countries within EU/EEA, as for export to countries outside the EU/EEA.
Legislation
- Regulations relating to wholesaler activities with medicinal products, 21 December 1993
- Regulation relating to manufacture and import of medicinal products, 2 November 2004
- Regulation relating to clinical trials on medicinal products for human use, 30 October 2009